More Than a Signature

The informed consent process is designed to ensure that patients understand risks. But new advances involved in genetic testing and tissue donation may make signing on the dotted line more complex than ever.By Stephen Ornes

Three days before Christmas in 1995, Linda Horton, a medical researcher in Nashville, Tenn., was diagnosed with a large, fast-growing tumor in her breast. She quickly began her treatment course: chemotherapy to shrink the tumor, followed by a mastectomy—her doctors then told her the cancer was stage II—and additional chemotherapy afterward.

Horton didn’t qualify for any clinical trials for her cancer, but had her oncologist found one, she probably wouldn’t have thought long about signing the informed consent form. Patients consent to a medical treatment or procedure, in theory, only after they’ve been given enough information to make a sound decision. But in the midst of a cancer diagnosis and treatment, feeling fully informed can be challenging—and many patients just want to move forward. “Would I have signed something if he asked me to?” Horton asks. “Yup.”

But nearly two decades later, Horton, now 63, is the manager of a cancer research lab at the Vanderbilt-Ingram Cancer Center in Nashville, and she thinks patients should slow down and learn all they can before putting their name on the dotted line.

Horton, who writes sections of clinical trial informed consent forms related to studies at the lab she manages, hasn’t forgotten what it’s like to face complex medical information under stressful and uncertain circumstances. Recently, to address similar concerns, researchers and institutions such as the National Cancer Institute (NCI) have been working to simplify clinical trial informed consent forms. Yet consent can come into play not only before ordinary treatment or a clinical trial, but also prior to genetic testing or tissue donation. And as informed consent is adapted to new technologies, becoming “informed” has—for some procedures—become increasingly complicated, even as understanding what you are consenting to may be more important than ever.

You give consent for medical treatment all the time: when you see a specialist, fill a prescription or have blood drawn for tests. Those events typically carry a low risk, and simply going through the actions of doing them equates to giving consent. Cancer treatments carrying higher risks require written consent.

During the informed consent process prior to treatment, patients and health care providers discuss a plan. A variety of information should be part of this discussion. For instance, you should learn about the benefits and risks of available treatment options, as well as the pros and cons of not receiving treatment.

The process may seem straightforward enough. But, notes Horton, many patients are making these decisions at a time when they “are terrified,” and when the deluge of information about complex therapies can be especially hard to digest. According to Horton, patients should take enough time to be comfortable with their decision. Ask questions of the health care team if any details are unclear, she advises, and discuss your plans with your loved ones. Asking your health care team if you can record your conversations with a voice recorder is recommended by many organizations, including the American Cancer Society.

If you are considering participating in a clinical trial, becoming adequately informed may feel harder because the possible benefits and risks of participation may not be fully known, and because you may continue to receive additional new information throughout the trial. The informed consent process should give you an understanding of the trial, including what is already known about the treatment or procedure from previous research. (See “What You Need to Know About Your Clinical Trial” for more information.)

Horton points out that clinical trial consent forms are much more patient-friendly than in years past. “I think there’s a lot more effort being put into making the patient comfortable” with the information before joining a clinical trial, she says. In the last 15 years, the NCI and many cancer centers and research institutions have been working to simplify the forms and add reader-friendly language. Recent revisions by the NCI, for instance, cut its typical consent form length from about 16 pages to seven pages.

Your Genes, Your InformationThough patients involved in the process of informed consent for clinical trials may find the forms less overwhelming than before, those facing informed consent for genetic testing may encounter new complexities. According to the National Institutes of Health, genetic tests are now available for mutations associated with more than 2,000 diseases, including some of the 5 to 10 percent of cancers that are believed to have a hereditary component.

There is inconsistency regarding what information is discussed during the informed consent process—typically led by a doctor or genetic counselor—prior to genetic testing for a mutation that increases cancer risk. Several groups do offer guidelines, however. Riley co-authored updated guidelines for cancer risk counseling that include suggestions for the consent process and were published in 2012 by the National Society of Genetic Counselors (NSGC). Among the recommendations for counselors: Talk to patients about their personal medical history as well as their family medical history going back three to four generations, discuss who can view the results of the genetic test, and address the test’s possible outcomes.

As part of the informed consent process, the counselor should also go through a cost-benefit analysis with the patient, Riley says. To do this, Riley helps patients understand their likelihood of having a mutation based on their personal situation. And then, he works with them as they decide: Is it worth it to pay, in some cases, thousands of dollars for this test?

Patients should also learn about their choices, according to the NSGC guidelines. For example, they may be told that they can choose to wait for the results of a genetic test before making a decision about treatment, or that they could begin treatment before their results are available, says Riley. Individuals who have not been diagnosed with cancer may be informed that options such as active surveillance and risk-reduction surgeries are available if testing reveals a mutation that can greatly increase their cancer risk.

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